Press Releases September 8, 2026 04:01 PM

Pyxis Oncology to Host Webcast to Present Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (2L+ R/M HNSCC)

Pyxis Oncology to present updated Phase 1 data of MICVO in advanced head and neck cancer via webcast

By Ajmal Hussain
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PYXS

Pyxis Oncology announced a live webcast to present updated clinical data from its Phase 1 study of micvotabart pelidotin (MICVO) as monotherapy in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The presentation will cover efficacy, safety, dosing details, and next clinical development steps. MICVO, a novel antibody-drug conjugate targeting the tumor microenvironment, has FDA Fast Track designation and is being evaluated alone and in combination with Merck's KEYTRUDA®.

Pyxis Oncology to Host Webcast to Present Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (2L+ R/M HNSCC)
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Key Points

  • MICVO is a novel antibody-drug conjugate targeting extracellular matrix component EDB+FN selectively expressed in tumors, aiming to improve treatment of difficult solid tumors like R/M HNSCC.
  • Updated Phase 1 monotherapy data will be disclosed including efficacy and safety at specific dosing in second-line and beyond recurrent/metastatic head and neck cancer patients.
  • MICVO holds Fast Track designation from FDA for R/M HNSCC patients progressing after platinum-based chemotherapy and anti-PD-(L)1 therapy, highlighting regulatory support.

BOSTON, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that it will host a live webcast on September 9, 2026 at 7:30 a.m. Eastern Time to present updated clinical data from its ongoing Phase 1 monotherapy study evaluating micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

The presentation will include the scientific rationale for Pyxis Oncology’s novel ADC, MICVO; implications of the evolving treatment landscape in R/M HNSCC; detailed analyses of patients treated at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap; updated efficacy and safety results from the expansion trial; and next steps in clinical development.

The event will feature Alan L. Ho, M.D., Ph.D., Chief, Head and Neck Oncology Service and Attending Medical Oncologist at Memorial Sloan Kettering Cancer Center, together with members of Pyxis Oncology’s management team.

To participate in the live event, please register using this link. An archived webcast will be available following the event on the Company's website at, https://ir.pyxisoncology.com.

About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment.

MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

To learn more, visit www.pyxisoncology.com or follow us on LinkedIn.

Pyxis Oncology Contact
[email protected]


Risks

  • Clinical data is early-phase (Phase 1) and efficacy/safety outcomes remain to be confirmed in larger trials, representing clinical development risk impacting biotechnology and oncology sectors.
  • Competitive landscape with existing immunotherapies like anti-PD-1 agents (e.g., KEYTRUDA) may affect market adoption and commercial potential.
  • Regulatory approval is not guaranteed despite Fast Track status; delays or negative findings in further studies could negatively impact stock and oncology treatment progress.

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